[Federal Register Volume 82, Number 68 (Tuesday, April 11, 2017)]
[Notices]
[Pages 17428-17430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07157]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Systematic Review of 
Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal 
Health Outcomes in Developed Countries

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for supplemental evidence and data submissions.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review of Systematic 
Review of Breastfeeding Programs and Policies, Breastfeeding Uptake, 
and Maternal Health Outcomes in Developed Countries, which is currently 
being conducted by the AHRQ's Evidence-based Practice CentersProgram. 
Access to published and unpublished pertinent scientific information 
will improve the quality of this review.

DATES: Submission Deadline on or before May 11, 2017.

ADDRESSES: 
    Email submissions: src.org">SEADS@epc-src.org.
    Print submissions: Mailing Address: Portland VA Research 
Foundation, Scientific Resource Center, ATTN: Scientific Information 
Packet Coordinator, P.O. Box 69539, Portland, OR 97239.
    Shipping Address (FedEx, UPS, etc.): Portland VA Research 
Foundation, Scientific Resource Center, ATTN: Scientific Information 
Packet

[[Page 17429]]

Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D 71, 
Portland, OR 97239.

FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262 
ext. 51723 or Email: src.org">SEADS@epc-src.org.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Systematic Review of 
Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal 
Health Outcomes in Developed Countries. AHRQ is conducting this 
systematic review pursuant to Section 902(a) of the Public Health 
Service Act, 42 U.S.C. 299a(a).
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Systematic Review of Breastfeeding Programs and 
Policies, Breastfeeding Uptake, and Maternal Health Outcomes in 
Developed Countries, including those that describe adverse events. The 
entire research protocol, including the key questions, is also 
available online at: https://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=2455
    This is to notify the public that the EPC Program would find the 
following information on Systematic Review of Breastfeeding Programs 
and Policies, Breastfeeding Uptake, and Maternal Health Outcomes in 
Developed Countries helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, please provide a summary, including the following 
elements: Study number, study period, design, methodology, indication 
and diagnosis, proper use instructions, inclusion and exclusion 
criteria, primary and secondary outcomes, baseline characteristics, 
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution will be very beneficial to the EPC Program. The 
contents of all submissions will be made available to the public upon 
request. Materials submitted must be publicly available or able to be 
made public. Materials that are considered confidential; marketing 
materials; study types not included in the review; or information on 
indications not included in the review cannot be used by the EPC 
Program. This is a voluntary request for information, and all costs for 
complying with this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program Web 
site and available for public comment for a period of 4 weeks. If you 
would like to be notified when the draft is posted, please sign up for 
the email list at: https://www.effectivehealthcare.ahrq.gov/index.cfm/join-the-email-list1/.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions.

The Key Questions

    KQ 1a. What is the effectiveness and harms of programs and policies 
on initiation, duration, and exclusivity of breastfeeding?
    KQ 1b. To what extent do the effectiveness and harms of programs 
and policies on initiation, duration, and exclusivity of breastfeeding 
differ for subpopulations of women defined by sociodemographic factors 
(e.g., age, race, ethnicity, socioeconomic status)?
    KQ 1c. To what extent do intervention-related characteristics 
(e.g., type of breast pump provided--manual or electric; delivery 
personnel) influence the initiation, duration, and exclusivity of 
breast feeding?
    KQ 2a. What are the comparative benefits and harms for maternal 
health outcomes among women who breastfeed for different intensities 
and durations?
    KQ 2b. To what extent do benefits and harms for maternal health 
outcomes differ for subpopulations of women defined by age, race, 
ethnicity, and comorbidity?

Population(s)

    KQs 1, 2: Childbearing women and adolescents; we will also search 
for evidence on subgroups of women defined by age, race, ethnicity, 
comorbidity, and socioeconomic status (including insurance status and 
payer type).

Interventions/Exposure

    KQ 1: Community, workplace, and health care system-based 
interventions aimed at promoting and supporting breastfeeding, 
including the following: Health plan benefits, state and federal 
policies or programs (e.g., WIC programs), hospital implementation of 
the BFHI, workplace or school-based programs, and others. For studies 
assessing the effectiveness of BFHI, we will include studies evaluating 
full and partial implementation (at least 3 steps) of the 10 steps.
    KQ 2: Exposure to breastfeeding.

Comparators

    KQ 1: No intervention (or usual practice); comparisons of two 
interventions that differ in content or intensity.
    KQ 2: No breastfeeding; shorter duration of breastfeeding (e.g., 
breastfeeding for 1 month vs. 12 months) and/or less intensive 
breastfeeding (e.g., exclusive breastfeeding vs. mixed feeding or 
formula feeding).

Outcomes

    KQ 1: Rates of breastfeeding initiation; duration and exclusivity 
of breastfeeding, adverse effects of interventions (e.g., guilt about 
not breastfeeding, workplace discrimination, and other reported harms).
    KQ 2: Postpartum depression, breast cancer, ovarian cancer, 
osteoporosis, cardiovascular outcomes (e.g., stroke, myocardial 
infarction), postpartum weight change, type 2 diabetes, hypertension.

Timing

    KQs 1, 2: We will have no minimum study duration or length of 
follow up.

Settings

    KQs 1, 2: Studies conducted in a developed country [``very high'' 
(KQs 1, 2) and ``high'' (KQ 1) human development index per the United 
Nations Development Programme 40.

[[Page 17430]]

Study Design

    KQ 1: Randomized and non-randomized controlled clinical trials; 
prospective cohort studies with concurrent control groups; systematic 
reviews; for studies assessing policy or system-level interventions, we 
will also include pre-post studies with repeated outcome measures 
before and after the intervention.
    KQ 2: Randomized and non-randomized controlled clinical trials; 
cohort studies; case-control studies; systematic reviews.

Sharon B. Arnold,
Acting Director.
[FR Doc. 2017-07157 Filed 4-10-17; 8:45 am]
 BILLING CODE 4160-90-P